Global Sr Project Manager - FSP (Open)
RemoteColombia
Job Summary
Lead cross-functional study teams to own day-to-day management of a global clinical study, driving operational strategy and alignment between global and regional execution. Develop and maintain study timelines, risk management plans, and enrollment strategies while overseeing country start-up, site activation, and closeout. Manage external vendors and CRO partners, track performance metrics, and resolve operational escalations to ensure contractual obligations and timelines are met. Monitor study budgets, forecasts, and resource gaps while identifying operational risks. Identify study risks early, lead mitigation and contingency planning, and handle escalations related to recruitment delays, protocol deviations, and data quality issues. Ensure study conduct follows ICH-GCP, local regulations, and SOPs to support inspection readiness and audit activities. Serve as the central operational contact for the study, communicating updates to senior leadership, regional teams, and sponsors. Monitor enrollment, data cleaning, query resolution, and database lock readiness while reviewing KPIs and operational metrics.
Required Qualifications
- Bachelor's degree: life sciences or related discipline
- At least 6+ years of relevant study management experience on a global level
- In-depth experience in clinical research: study management, monitoring, data management
- Must have exposed to clinical study management 'end-to-end'
- Globally : NA, EMEA, APAC, LATAM – China & Japan
- Must have proven experience from study feasibility to CSR
- Must have at least Ph II and PIII experience
- Must have cross-functional leadership proven experience
- Able to drive internal and external meeting
- Able to input in clinical protocol, ICF, and other study plan
- Savvy in clinical study risk management and clinical systems
- Strong experience in clinical budget management
- Strong experience with vendor management including CRO
- Exposed to competent authority Inspections (FDA, EMA, MHRA, PMDA...)
- Fluent in English, to the level they can negotiate and discuss (adapt message) related to complex topics with any Clinical team member
- Excellent stakeholder management and communication skills (oral and written)
- Outstanding interpersonal skills
- Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
- Strong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
- Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)
Desired Qualifications
- Previous in-depth Oncology experience
- Africa is an asset
- PI & PIV is an asset
- Being involved in studies pivotal for drug file registration is an asset
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